Breakthrough: FDA Approves First Treatment in 22 Years for a Common Type of Bladder Cancer
Adjuvant nivolumab improves disease‑free survival after radical cystectomy in patients with high‑risk muscle‑invasive urothelial carcinoma.
In this phase 3, multicenter, double‑blind, randomized trial, patients with high‑risk muscle‑invasive urothelial carcinoma who had undergone radical surgery received either nivolumab or placebo every 2 weeks for up to 1 year. The median disease‑free survival was 20.8 months with nivolumab versus 10.8 months with placebo, and the proportion of patients alive and disease‑free at 6 months was 74.9% versus 60.3%. Similar benefits were seen in the PD‑L1–positive subgroup.
Adjuvant therapy for high‑risk muscle‑invasive urothelial carcinoma lacks proven benefit; this study demonstrates that nivolumab significantly extends disease‑free survival, offering a potential new standard of care after radical surgery.
Evidence level: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.